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Computer-Based Cognitive Behavioral Therapy for Chronic Pain in Opioid Treatment (IMPACT Trial)

N/A

Recruiting

Led By Alicia Heapy, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Enrolled in methadone or buprenorphine treatment at Liberation

Eligible participants will be 18 years of age or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 weeks

Awards & highlights

IMPACT Trial Summary

This trial is testing a new cognitive behavioral therapy program for people with chronic pain who are also being treated with buprenorphine or methadone. The therapy program includes components from an existing program (CBT4CBT) and a new program (COPES). The trial will compare the new program to standard care in a group of 160 people, measuring outcomes such as pain interference and adherence to agonist treatment.

Who is the study for?

Adults over 18 with opioid use disorder (OUD) who are on methadone or buprenorphine treatment and have chronic pain. They must be able to walk a block, speak English at a basic level, and not have severe health issues or untreated mental disorders that could interfere with the study.Check my eligibility

What is being tested?

The trial is testing an integrated web-based program combining cognitive-behavioral therapy (CBT4CBT) and Cooperative Pain Education Self-Management (COPES). It aims to improve adherence to medication-assisted treatment for OUD and manage chronic pain better than standard care alone.See study design

What are the potential side effects?

Since this is a behavioral intervention involving education and self-management without medications, there may not be direct side effects like those seen with drugs. However, participants might experience discomfort while learning new coping skills.

IMPACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently in a methadone or buprenorphine program at Liberation.

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I am 18 years old or older.

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I have experienced pain on most days for the last six months.

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I have chronic pain with a severity of 4 or more on a scale of 0-10.

IMPACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence to opioid agonist treatment (OAT)

Change in PROMIS 6-item Pain Interference Short Form

Secondary outcome measures

Drug Use

IMPACT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CBT4CBT-CopesExperimental Treatment1 Intervention

Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily texts with a link to a survey.

Group II: Standard care treatment as usual (TAU)Active Control1 Intervention

Individuals will receive buprenorphine or methadone in addition to regular individual or group sessions as offered by the clinic

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH

833 Previous Clinical Trials

669,293 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,716 Total Patients Enrolled

Yale UniversityLead Sponsor

1,852 Previous Clinical Trials

2,738,281 Total Patients Enrolled

Media Library

CBT4CBT COPES Clinical Trial Eligibility Overview. Trial Name: NCT05204576 — N/A

Opioid Use Disorder Research Study Groups: Standard care treatment as usual (TAU), CBT4CBT-Copes

Opioid Use Disorder Clinical Trial 2023: CBT4CBT COPES Highlights & Side Effects. Trial Name: NCT05204576 — N/A

CBT4CBT COPES 2023 Treatment Timeline for Medical Study. Trial Name: NCT05204576 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still space available to participate in this investigation?

"Affirmative. According to the information found on clinicaltrials.gov, this medical trial is currently looking for participants, with an initial posting date of July 15th 2022 and most recent edit being made on September 9th 2022. The study requires 160 patients from one site location."

Answered by AI

What is the maximum intake capacity of this investigation?

"Affirmative. According to information hosted on clinicaltrials.gov, this medical trial is currently accepting participants. It was first publicized on July 15th 2022 and the most recent edit occurred September 9th 2022; it requires 160 patients at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Computer Based Treatment for Cognitive Behavioral Therapy and Cooperative Pain Education and Self-Management

2022. "Computer Based Treatment for Cognitive Behavioral Therapy and Cooperative Pain Education and Self-Management". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05204576.

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